Gastric Cancer Sentinel Lymph Node Mapping

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03049345
• Date of registration: 06/02/2017
• Prospective Registration: No
• Primary sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Public title: Gastric Cancer Sentinel Lymph Node Mapping
• Scientific title: Gastric Cancer Sentinel Lymph Node Sampling: Refining Patient Selection for Organ Sparing Resection of Early Gastric Cancer in a North American Context
• Date of first enrolment: July 1, 2016
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03049345
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Carmen L Mueller, MD MEd

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients who are deemed healthy enough to withstand laparoscopic or open anatomic
gastrectomy with extended regional (D2) lymphadenectomy will be eligible. Patients
much have biopsy-proven, single lesion, <4cm gastric adenocarcinoma, of stage
cT1/T2/T3 N0 M0.

Exclusion Criteria:

- Not able to withstand anatomical gastric resection with D2 lymphadenectomy, patient
refusal, N+ve disease on pre-op work up, disease progression before surgery



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Early Gastric Cancer

Gastric Cancer

Sentinel Lymph Node

Intervention(s)

Drug: Methylene Blue 20 MG/ML

Drug: Radioactive Tracers

Procedure: Sentinel Lymph Node Sampling

Primary Outcome(s)

Number of patients in whom sentinel lymph node status accurately predicts true nodal status after anatomical gastrectomy and complete pathological examination [Time Frame: 3-4 weeks after study completion]

Specificity of Sentinel Lymph Node Sampling Method [Time Frame: 3-4 weeks after study completion]

Sensitivity of Sentinel Lymph Node Sampling Method [Time Frame: 3-4 weeks after study completion]

Secondary Outcome(s)

3 year Disease free survival rate [Time Frame: 3 years after study completion]

conversion to open [Time Frame: at time of surgery]

3 year overall survival rate [Time Frame: 3 years after study completion]

Length of stay [Time Frame: 90 days from study completion]

Adverse events due to SLN sampling technique [Time Frame: at time of surgery]

Adverse surgical events [Time Frame: 30 days after study completion]

Patient mortality [Time Frame: 90 days after surgery]

R0 Resection rate [Time Frame: 3-4 weeks after study completion]

Secondary ID(s)

14-288-GEN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors